Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Customized |
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Batch No. | HF170310 | Quantity | 5.0kgs |
Mfg. Date | Mar. 10, 2017 | Package | As required |
Rep. Date | Mar. 13, 2017 | Exp. Date | Mar. 09, 2019 |
Items | Standards | Results | |
Appearance | Light yellow to yellowish brown crystalline powder | Complies | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Solubility | Soluble in acidic aqueous media, becoming less soluble as pH increases. | Complies | |
Clarity of Solution | 1% sample solution in water(pH=1~2) should not more intense than the reference solution B9 and reference suspension | Complies | |
Water Content | ≤1.00% | 0.24% | |
Heavy Metals | ≤20ppm | Complies | |
Residue on Ignition | ≤0.10% | 0.07% | |
Assay of Succinic Acid | 19.4%~23.4% | 20.8% | |
Residual Solvents | Isopropanol: ≤ 5000ppm | ND | |
Methylbenzene: ≤ 890ppm | ND | ||
Methyl Isobutyl Ketone: ≤ 5000ppm | ND | ||
Heptane: ≤ 5000ppm | ND | ||
Related Substances | Any single impurity: ≤0.30% | 0.26% | |
Total impurities: ≤1.00% | 0.76% | ||
Assay (HPLC basis on drying) |
98.0%~102.0% | 99.12% | |
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |